Human Papilloma Virus Vaccination in Girls With Cystic Fi... | NCT03653377

Studies
Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)

NCT03653377

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Jun 18, 2021Actual

Enrollment

81Actual

Phase

Not provided

Conditions

Mucoviscidosis

Interventions

Self administrated questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-A01314-51	Other Identifier	ID-RCB

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2018Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

Apr 30, 2019Actual

First Submitted Date

Aug 29, 2018

First Submission Date that Met QC Criteria

Aug 29, 2018

First Posted Date

Aug 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2021

Last Update Posted Date

Jun 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV). Vaccination against HPV, offered to all girls aged 11 to 14 is an effective method of prevention against cervical pathology. Despite this, vaccination coverage against HPV remains low in France. A proportion of women with cystic fibrosis may be involved in transplantation, a factor associated with a higher risk of HPV carriage and cervical pathology. An over-risk of cervical pathology would also be present in women with non-transplanted cystic fibrosis. Particular attention to vaccination should therefore be included in this population.

Objectives of the study The main objective of the study is to estimate the frequency of HPV vaccination in young girls with CF over 9 years and followed in a pediatric CF center.

The secondary objectives are to know:

The type of vaccine used (bivalent / quadrivalent / nonavalent)
The proportion of vaccinated girls with respect of the vaccination schedule (number of injections / spacing between doses)
Reasons for non-use of vaccination

Study design The study will last 12 months. It is a cross-sectional, non-interventional, multicenter conducted by self-administered questionnaire.

Population

young girls aged 9 years or older with Cystic fibrosis
Followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
With parents who did not object to participation in the study

Number of subject: 62 patients

Expected results

Knowledge of HPV vaccination coverage in young girls with CF.
Sensitization of patients, their parents and health professionals to HPV vaccination. Understand the barriers and reasons for refusing vaccination to promote actions to improve immunization coverage.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with self-administered questionnaire			Other: Self administrated questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self administrated questionnaire	Other	Questionnaires are distributed to patients with their parents during their visit to the CF center.	Patients with self-administered questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HPV vaccination	The outcome measure is having HPV vaccination. This information is collected through a self-questionnaire, completed by the patients or their parents, during a visit to the CF center	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

young girls aged 9 years or older
patients with Cystic Fibrosis
patients followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
patients with parents who did not object to participation in the study

Exclusion Criteria:

-patients who refuse to answer to the self-administrated questionnaire

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Cohort of minor girls with cystic fibrosis older than 9 years, followed in a pediatric Mucoviscidosis Resource and Competence Center (MRCC).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christine ROUSSET-JABLONSKI, MD	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Mucoviscidose, Pneumologie		Bron			France
Hôpital d'Estaing

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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Browse Branches

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